Senior Manager, Quality Assurance

At Spy Glass Pharma (NASDAQ: SGP), we are focused on improving and preserving the vision of patients living with chronic eye diseases, while minimizing the burden treatment can place on their daily lives. We are advancing innovative long-term ophthalmic drug delivery technologies designed to provide sustained therapy through cataract surgery and help improve patient outcomes.

We have built a highly collaborative team with deep expertise across ophthalmology, drug delivery, pharmaceuticals, and medical devices. Our scientists, engineers, and clinical leaders bring decades of experience developing and commercializing breakthrough technologies, united by a shared commitment to patients and our guiding principle: “We create for patients.” That mindset shapes how we build our products, our teams, and our culture.

Backed by strong clinical progress, significant funding, and a growing organization, Spy Glass Pharma is entering an exciting stage of growth as we advance our lead program, the Spy Glass BIM-IOL, through Phase 3 clinical development.

The Senior Manager of Quality Assurance role involves support for the Research & Development (R&D) and Operations teams, ensuring that all processes meet regulatory requirements and company Quality Management System. This position reports to the Senior Director, Quality with direct oversight of one other QA team member currently. This position will also play a key role that supports clinical and manufacturing operations.

The Senior Manager ensures compliance with cGMP, GCP and GLP requirements through direct oversight of QA process including document control, supplier qualification, deviations/CAPA and batch disposition, and serves as a trusted cross‑functional partner as the company advances from clinical development toward commercialization.

• Provide direct leadership, coaching, and performance management for the Quality Assurance Engineer; setting team priorities, workload, and individual development plans; delegate and review work to build team capability and bench strength.
• Maintain QMS compliance with both drug regulations (21 CFR Part 210/211) and medical device requirements (21 CFR Part 820 / ISO 13485), specifically addressing 21 CFR Part 4 for combination products.
• Responsible for managing GxP quality requirements supporting product development, phase appropriate and lifecycle management of clinical products, and the commercialization and launch.
• Provide Quality oversight to ensure clinical and commercial product is manufactured, tested, stored, and distributed according to cGMP’s and other applicable regulations.
• Ensure QA review and approval of records, and personally perform and provide key QA duties/support to CMC/Device development and operations teams during product development, clinical and commercial manufacturing including:
  • Review and approve Master Production Records from Contract Manufacturing Organizations to include Drug Substance manufacturing, Drug Product manufacturing, Finished Drug Product labeling and packaging operations, and external laboratory oversight.
  • Reviews and approves executed records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificate of conformance
  • Perform product release for clinical investigational and commercial distribution
  • Raw Material Qualification
  • Review and approve validation protocols and validation reports as required.
  • Provide Quality assessments and approvals for internal and external Change Controls impacting clinical or commercial products

• Serve as designated representative with critical CMOs and work with technical operations to address manufacturing issues at the CMO.

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